Science & Research
Microarrays and next-generation sequencing represent core technologies in pharmacogenomics and toxicogenomics; however, before these technologies can successfully and reliably be used in clinical practice and regulatory decision-making, standards and quality measures need to be developed. The MAQC project is helping improve the microarray and next-generation sequencing technologies and foster their proper applications in discovery, development and review of FDA regulated products. Everyone is invited to participate in the MAQC project.
- February 11, 2005: Phase I of the MAQC project (MAQC-I) on microarray technical performance launched
- June 5, 2006: MAQC-I manuscripts submitted
- September 8, 2006: MAQC-I results published in September 2006 issue of Nature Biotechnology
- September 8, 2006: MAQC-I datasets made publicly available
- September 21, 2006: MAQC-II on predictive models (signatures) launched
- August 28, 2007: “Pharmacogenomic Data Submissions — Companion Guidance” released
- December 16-17, 2008: MAQC-III (or SEQC) on next-generation sequencing launched
- March 2009: MAQC-II manuscripts submitted
- August 2010: MAQC-II results published in August 2010 issues of Nature Biotechnology and Pharmacogenomics Journal
Please address questions and suggestions about the MicroArray Quality Control project to Dr. Leming Shi at Leming.Shi@fda.hhs.gov or Dr. Weida Tong at Weida.Tong@fda.hhs.gov or Reagan Kelly at Reagan.Kelly@fda.hhs.gov.